Pancrelipase
NDC Package 39822-0205-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pancrelipase is a . Marketed by X-gen Pharmaceuticals, Inc., this product is identified by NDC 39822-0205 and is authorized under FDA application NDA022210.

Identification & Billing

NDC Package Code
39822-0205-1
Package Description
1 BOTTLE in 1 CARTON / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
39822-0205
11-Digit Billing Format
39822020501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Pancrelipase
Dosage Form
-

Regulatory & Marketing

Labeler Name
X-gen Pharmaceuticals, Inc.
FDA Application #
NDA022210
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-22-2009
End Marketing Date
03-31-2018
Listing Expiration
03-31-2018
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 39822-0205-1 identifies a specific commercial package of 1 bottle in 1 carton / 100 capsule, delayed release in 1 bottle of Pancrelipase, labeled by X-gen Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by X-gen Pharmaceuticals, Inc. on September 22, 2009. The current certification is valid through March 31, 2018.

How is this X-gen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39822020501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
39822-0205-1
11-Digit CMS (5-4-2)
39822-0205-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.